第⼋节注意事项
“注意事项”也是药品说明书中的重要内容之⼀。为了安全⽤药,⼚商在本项中特别强调应注意的事项,其中主要包括:正确的剂量和⽤法,超过剂量时的应急措施,⽤药对象,可能出现的较严重的副作⽤及治疗⽅案,药物的配伍,药液的配制、使⽤及保管等、⽅⾯的注意事项。现就本项内容详细介绍如下:
1. 本项常⽤的英语表⽰法:
Precaution(s)注意事项 Special note(caution, precaution)特别注意
Caution(s) 注意事项 N.B. 注意
Noto 注意 Warning(s) 警告
有时也⽤:
Important 重要事项 Important for the patients 患者须知
2. 本项中常见的检查项⽬:
blood count ⾎细胞汁数 Kidney (renal) function 肾功能
blood picture(hemogram)⾎象 Liver(hepatic)function 肝功
blood level ⾎浓度 rum concentration ⾎清浓度
blood pressure ⾎压 rum creatinine test ⾎清肌酸酐检验
clotting time 凝⾎时间 urine routine(examination)尿常规
creatinine clearance 肌酸酐清除率
3. 本项的特点是内容长短不⼀,有难有易;词汇量⼤,涉及⾯⼴,既有普通词汇,也有⼤量的专业词汇及编写词。许多词汇、结构和句型可在药理作⽤、适应症、禁忌症、剂量和⽤法、副作⽤,贮藏等项中见到。从英语结构上分析,句型变化较多,长句、难句也屡屡出现,是⽐较难读的⼀个项⽬。
例1 Warnings and precautions: Ciprofloxacin should be ud with caution in epileptics and patients with a history of CNS disorders and only if the benefits of treatment are considered to outweight the risk of possible CNS side-effects.
警告和注意事项:癫痫病⼈及有中枢神经系统病史的患者慎⽤环丙沙星,仅当认为疗效超过可能产⽣的中枢神经系统副作⽤的危险时才可使⽤。
例2 Ciprofloxacin could result in impainnent of the patients ability to drive or operate machinary, particularly in conjunction with alcohol.
环丙沙星能损害⼈们驾驶汽车或操纵机器的能⼒,尤其是在饮酒之后。
例3 Warnings: Vepeside should be administered under the supervision of a qualified physicain experienced in the u of cancer chemotherapeutic agents.
警告:泛必治应该在使⽤治疗癌症的化疗制剂⽅⾯有经验、有资格的医⽣的监护下使⽤。
例4 The most rious risk associated with anticoagulant therapy with sodium warfarin are hemorrhage in any tissue or organ and less frequently, necrosis and/ or gangrene of skin and other tissues. The risk of hermorrhage is related to level of intensity and the duration of anticoagulant therapy.
⽤华注林钠进⾏抗凝治疗产⽣的最严重的危险就是组织或器官出⾎,以及不⼤常出现的⽪肤和其他组织的坏死和(或)坏疽。出⾎的危险与抗凝治疗的药物浓度(⽔平)及疗程长短有关。
例5 The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil count below 500/mm3 is an indication to withhold further therapy until the blood counts have sufficiently recovered.
⾎⼩板数低于s0,000/mm3 或绝对中性⽩细胞数低于500/mm3 ,表明不能继续使⽤本品治疗,待⽩细胞计教充分恢复后才能继续⽤药。
例6 Warfarin therapy should be discontinued when warfarin is suspected to be the cau of developing necrosis and heparin therapy may be considered for anticoagulation.
当怀疑华法林治疗引起坏死时,则须停⽌治疗,并且考虑使⽤肝素治疗。
例7 Dosage should be controlled by periodic determinations of prothrombin time(PT) or other suitable coagulation tests.
必须定期检查凝⾎酶原时间(PT),或做其他相应的凝⾎试验来控制剂量。
例8 Plea note Cerebral convulsive dia is regarded as a relative contraindication for examinations in the subarachnoid space. If after careful consideration, the examinations are nevertheless performed, all equipment and medicines necessary to counter any convulsions may oc
cur must be prepared ready for u beforehand.
请注意:脑惊厥被认为相对禁⽌进⾏蛛膜下腔检查,如经谨慎考虑后、仍要进⾏这些检查时.必须事先备妥应付可能发⽣惊厥所需的所有设备与药品。
例9 Caution must be exercid in the ca of hypernsitivity to iodinated contrast media, latent hyperthyroidism and bland nodular goitre.
对碘造影剂过敏、隐匿性甲状腺亢进和轻微甲状腺肿的病例,应慎重。
例10 Caution Alcohol intake may enhance nitrate effects and occasionally induce hypotension with subquent impairment of reactivity. During the first three months of pregnancy drugs should only be ud on the express direction of the attendant physician. Isket spray should not be stored at temperatures above 25。C! Temperatures above 40 ℃ are to be be avoided, even for bried periods! Do not force canister open, even when empty!
注意:饮酒可增强硝酸盐的作⽤、偶尔引起低⾎压,继⽽损害反应⼒。妊娠三个⽉时,只有在监护医⽣明确指导下才可使⽤本品。异舒吉喷雾剂的贮存温度不应超过25℃!避免超过40℃。即使短时间也不可!不要⽤⼒开罐,即使空罐时也不可⽤⼒开!勿使⼉童接触本品
例11 As with all new drugs, patients should be followed carefully so that any side-effects or unusual manifestations of drug idiosyncrasy may be detected. If any allergic reaction to Keflex occurs, the drug should be discontinued and the patient treated with the usual agents.
像使⽤所有新药⼀样,应细⼼地随访患者,以便观察任何副作⽤或药物特异反应。如果出现对头抱菌素IV的过敏反应,应停药,并⽤常规药物治疗患者。
例12 In patients with normal renal function, chronic hypercalcemia may be associated with an increa in rum creatinine. While this is usually reversible, It is important in such patients to pay careful attention to tho factors which may lead to hypercalcemia.
对于肾功能正常的患者,慢性⾼钙⾎症可能与⾎清肌酸酐增多有关。这通常虽然是可逆的,然⽽对这样的病⼈,密切注意可能导致⾎钙过多的各种因素是很重要的。
例13 Precautions ⼀Avoid the concomitant u, in the abnce of special monitoring laboratory of parameters, of anticoagulants or aspirin. ⼀Inform the attending physician in the event of bleeding or of the occurence of a hematoma.
注意事项:在⽆化验室参考指标的专门监测情况下,避免与抗凝剂或阿司匹林合⽤。如发⽣出⾎或出现⾎肿,应通知主治医⽣。
例14 Periodical examination of hepatic or renal function and blood picture is desirable since Kedacillin may increa SGOT. SGPT and BUN, and decrea erythrocyte and leucocyte.
磺苄青霉素钠可使⾎清⾕-草转氨酶,⾎清⾕-丙转氨酶和⾎液尿素氮增⾼,使红细胞和⽩细胞减少.所以要定期检查肝、肾功能和⾎象。
例15 N.B.Transference from insuline to Glutril may be attempted in ca of maturity-ont diabetes with obesity;dosage is bad upon the result of the necessarily frequent metablic tests.
注意:伴有肥胖症的成年型糖尿病患者,可试从胰岛素改⽤格路特利治疗,剂量应以必须经常进⾏的代谢试验为依据。
第九节包装
1“包装”在英⽂药品说明书中的表⽰法有许多,最常⽤的是Pack(Package)和Supply,例如:
Pack(s) (Packing(s))包装 Supplys(Supplied) 包装
Package(s) 包装 How Supplied 包装⽅式
Packing for Hospital 医院⽤包装 Method of Supply 包装⽅式
Package Quantitiess( Quantity)包装量
此外还有,
Prentation 包装 Hospital (Size) Packs 医院⽤包装
Availability 包装 Trade Packs(Packings)商品包装
Mode(Form)of Issue 包装
2 常见的包装单位(⼯具)的英语表⽰法:
ampoule(s) 安瓿 carton 纸盒
blister pack(package)铝塑包装(⽔泡眼包装)
pack 包
blister strip 铝塑条状包装(⽔泡眼条包装)
sheet 张
bottle 瓶
strip 条
box 盒
tube 管
canist 罐
vial 玻璃⼩瓶
3 药物的常见剂型的英语表⽰法:
aerosol (spray, inhaler) ⽓雾剂 ampoule 针剂
capsules 胶囊 oral solution ⼝服液
coated(-)tablets 包⾐⽚ pill 丸剂
cream 乳膏 powder 粉剂
derm TTS ⽪肤贴膏 retard capsules (tablets)缓释胶囊(⽚)
dregees 糖⾐丸 scored-tablets 刻(划)痕⽚
drops 滴剂 solution 溶液剂
emulsion 乳剂栓剂 sugar-coated tablets 糖⾐⽚
film-coated tablets 薄膜⽚。膜⾐⽚
suppositories 栓剂
granule 颗粒 suspension 悬浮剂,混悬剂
injection 注射剂,针剂
sustainedrelea tablets 恒(缓)释⽚
liniment 搽剂 syrup 糖浆
liquid 液剂 tablets ⽚剂
ointment 软膏
4 本项的结构特点;内容结构简单,多为不完全句,或仅仅列出包装⼯具、剂型、装量等,词汇量容易阅读。
例1 Prentation 30 capsules.
包装:30粒胶囊装。
例2 Packages:Box containing one 100 mg bottle
包装:盒装,每盒1瓶,每瓶100 mg。
例3 Packing Bottle of 12 capsules 250 mg and 500 mg.Bxo of 12 capsules 250 mg in blister.
Bottle for pediatri u (granulated): 20 gm granulated contain 1 gm ampicillin, The content of the spoon included in the packing corresponds to 100 mg ampicillin.
包装瓶装12粒胶囊,每粒含量250或500mg。盒装12粒胶囊(⽔泡眼包装),每粒含量250mg。瓶装⼉童⽤颗粒剂:20克颗粒剂每瓶含有 1 g 氨苄青霉素。附在包装内的⼀匙的量,相当于1O0 mg 氨苄青霉素。
例4 Mode of issue Ceopran Is issued in vials containing 250 mg, 500 mg and 1 gram of cephaloridine.
包装⽅式本品⼩瓶包装,内装 250mg、500mg及 1 g 头抱菌素II。
例5 Trade packs Trade packs containing 50 and 100 sugar coated tablets.
商品包装 50 及 100 糖⾐⽚包装。
例6 Packs(Madopar)250: Cross-scrored tablets each containing 200mg levodopa+50 mg benrazide.
包装美多巴“250”刻痕⽚,每⽚含200mg左族多巴50mg羟苄丝肼。
例7 Method of supply Tablets in tubes, each containing 30 tablets. Paint in glass bottles of 24 ml.Meladinine is supplied only on prescription.
包装⽅式管装⽚剂.每管30⽚。玻璃瓶装搽剂,每瓶24ml。敏⽩灵只按处⽅供药。
例8 Availability Syrup: Orbenin syrup is available in bottles containing reconstitutable powder for pr
eparing an aqueous solution. When dispend each 5 ml teaspoonful contains 125mg cloxacillin as the sodium salt.
包装糖浆:全霉林糖浆为瓶装,内含可供再配制⽔溶液的粉末。配制后的每茶匙5ml药液中含125ml 邻氯青霉素钠盐,
例9 How supplied Tablets: Coumadin (crystalline Wartarin Sodium USP), For oral u, single scored imprinted numericallyand Packaged in bottles with potencies and colors as follows:
包装⽚剂:⾹⾖定(结晶华法林钢⼀美国药典标准)。供⼝服。药⽚上有⼀条划痕,印有数字。瓶装,效价及颜⾊如下:
例10 Also available in Hospital Unit-Do blister package of 100.
也提供医院⽤的单位剂量的铝塑包装,(每包〕100⽚装。
例11 Temaril 250:white, film-coated tablets marked on one side with 250, each tablet containing 291.5mg ciprofloxacin hydrochloride monohydrate (equivalent 50 250mg ciprofoxacin).
替马利尔25U:⽩⾊有刻痕标记的薄膜⽚,⼀⾯刻有“250mg”字样、每⽚含 291.5mg 盐酸环丙沙星-⽔合物(相当于
250mg环丙沙星)。
例12 Packs Standard packs of 20 dregees Hospital packs of 100,500 and 1000 dregees.
包装标准包装为20粒糖⾐九。医院⽤包装为100,500及1000粒糖⾐丸。
例13 Package ouantities Becona Nasal Spray is a metered-do aerosolsol with a specially designed nasal applicator. Each canister provides 200 sprays.
包装喷雾剂是⼀种⽓雾剂.配有专门设计可供⿐⽤的喷雾器,每罐可喷雾 200次。
第⼗节贮存
“贮存”的英语常⽤表⽰法是Storage。本项中常⽤的⼀些短语有:
store (keep) in a cool and dry place 存于于阴凉⼲燥处
away from light 避光
away from children 勿让⼉童接触
protect from light (heat) 避光(热)
out of (the) reach of children 勿让⼉童触及
prevent moisture 防潮
本项的句⼦较简单多为⼀简单句,其中多为祈使句;⽤词也不多。
例1 store medicines carefully. Keep away from children.
注意保存.勿让⼉童接触。
例2 Stroe below 25℃ protecting from freezing and light.
存于25℃以下,防冻,避光。
例3 Validity and storage. The solution will keep for five years if stored at a emperature below +20℃.
有效期及贮法:放置于20℃以下可保存5年。
例4 Storage instructions: Protect from heat and light.
贮存⽅法;避光及防热贮存。
例5 To be stored in a dry place at a temperature not above 25℃.
存于不⾼于25℃的⼲燥之处。
例6 Do not store the suppositories over 25℃.
本栓剂不得存于25℃以上的温度。
例7 store at below 25℃ and protect from moisture,
存于25℃以下,防潮。
例8 The solution should be prepared immediately prior to u, but can be stored at 4℃ or up to one week.
药液应在配制后⽴即使⽤,但在4℃下可贮存⼀周。
有时也有较复杂的结构,或较多的内容,如:
例9 Ampoules and unopened nasal spray bottles should should be stored in a refrigerator (2—8℃). Onceopened the nasal spray bottle must be kept at room temperature; it should be kept in the uprigh
t position and ud for a maximum of 4 weeks. Like all drugs,Miacalcic should be kept out of reach of children.
安瓿或未开启的喷雾剂瓶应存于冰箱(2-8℃)中。喷雾剂瓶⼀旦开启。就应于室温下保存、药瓶应直⽴存放,使⽤时间最多为4周。与其他药物⼀样,密钙息应妥善保存,勿让⼉童接触。
例10 Protect from light. Store in carton until contents have been ud. Store at controlled room temperature(59⼀86F,15℃⼀30℃). Dispen in al tight, light-resistant container as defined in the U.S.P.
避光保存。药⽚在使⽤前于纸盒中保存。在恒温室温(59~86F,15℃⼀30℃)下保存。调剂时,使⽤美国药典规定的密闭,避光容器。
例11 Fungizone intravenous in powder form should be stored in the refrigerator, protected against exposure to light. The concentrate may be stored in the dark, at room temperature for 24 hours, or at refrigeratortemperatures for one week with minimal loss of potency and clarity. Any unud material should then be discarded.
两性霉素B粉剂应避光存于冰箱中。浓缩液可存于暗处,室温下可保存Z4⼩时,或可在冰箱温度下保存⼀周,其效价及澄明度变化极⼩。那以后⼀切尚未⽤的药物就应弃之。
第⼗⼀节其他项⽬
上述10项是绝⼤多数英⽂药品说明书中必备项⽬,但是许多说明书中还常常出现其他⼀些项⽬。例如: